BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 24780341 · Received April 3, 2026

    Report

    Report Number
    3013164176-2026-02960
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 3, 2026
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618675
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF A INFRARENAL ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. PRE-PROCEDURE COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) PERFORMED ON (B)(6), 2025, DETERMINED THE MAXIMUM DIAMETER OF THE ABDOMINAL AORTA MEASURED 50MM. SUCCESSFUL ACCESS, DELIVERY, AND ACCURATE DEPLOYMENT OF THE DEVICES TO THEIR INTENDED LOCATION, AND RETRIEVAL OF THE DELIVERY SYSTEM AND TECHNICAL SUCCESS WERE REPORTED. THERE WERE NO CORRECTIVE PROCEDURE(S) OR COMPLICATIONS RELATED TO THE DEVICE OR PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME (SELF-CARE) ON (B)(6), 2026. ON (B)(6), 2026, REVIEW OF FOLLOW-UP IMAGING BY GORE IMAGING SCIENCES (GIS) REPORTS THERE APPEARS TO BE COMPRESSION OF THE CONTRALATERAL LEG ON THE LEFT SIDE, LIKELY DUE TO LIMB COMPETITION. THIS AREA MEASURES ~ 14 MM ON THE PRE-IMPLANT CTA. ADDITIONALLY, THERE APPEARS TO BE A LACK OF WALL APPOSITION AT THE PROXIMAL END OF THE TRUNK. THE SITE/CSD DOES NOT PROVIDE RECORD OF THE FOLLOW-UP IMAGING TO DATE. THERE ARE NO INDICATED REINTERVENTIONS SCHEDULED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841811 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132618675

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| O